Valsts: Lielbritānija
Valoda: angļu
Klimata pārmaiņas: MHRA (Medicines & Healthcare Products Regulatory Agency)
Ursodeoxycholic acid
Dr. Falk Pharma UK Ltd
A05AA02
Ursodeoxycholic acid
500mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 01090100; GTIN: 5060096430452
URSOFALK 500MG FILM-COATED TABLETS (ursodeoxycholic acid) PATIENT INFORMATION LEAFLET READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. * Keep this leaflet. You may need to read it again. * If you have any further questions, ask your doctor or pharmacist. * This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. * If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet, see section 4. Your medicine is called Ursofalk 500mg film-coated tablets but will be referred to as Ursofalk tablets throughout the rest of this leaflet. WHAT IS IN THIS LEAFLET: What Ursofalk tablets are and what they are used for What you need to know before you take Ursofalk tablets How to take Ursofalk tablets Possible side effects How to store Ursofalk tablets Contents of the pack and other information WHAT URSOFALK TABLETS ARE AND WHAT THEY ARE USED FOR Ursofalk tablets contain the active substance ursodeoxycholic acid (UDCA). Small amounts of UDCA are found in human bile. URSOFALK TABLETS ARE USED: – for the treatment of primary biliary cirrhosis (PBC) a condition where the bile ducts in the liver become damaged leading to a build-up of bile. This may cause scarring of the liver (cirrhosis of the liver). The liver should not be so damaged that it is not functioning properly. – to dissolve cholesterol gallstones. These stones must not be visible on a plain X-ray (radiolucent) and be no larger than 15 mm in diameter because they will not dissolve with UDCA. The gall bladder must still be working despite the gallstone(s). – for liver disease associated with a condition called cystic fibrosis in children aged 6 to 18 years WHAT YOU NEED TO KNOW BEFORE YOU TAKE URSOFALK TABLETS DO NOT TAKE URSOFALK TABLETS IF: – You are, or have been told you are, allergic (hypersensitive) to bile acids like UDCA or Izlasiet visu dokumentu
OBJECT 1 URSOFALK 500MG FILM-COATED TABLETS Summary of Product Characteristics Updated 12-Jan-2015 | Dr. Falk Pharma UK Ltd 1. Name of the medicinal product Ursofalk 500mg film-coated tablets 2. Qualitative and quantitative composition One Ursofalk 500mg film-coated tablet contains 500mg of ursodeoxycholic acid (UDCA) as the active substance. For a full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablets Appearance: white, oval, biconvex film-coated tablets with a breakline on both sides. The tablet can be divided into equal doses. 4. Clinical particulars 4.1 Therapeutic indications For the treatment of primary biliary cirrhosis (PBC), provided there is no decompensated hepatic cirrhosis. For the dissolution of cholesterol gallstones in the gall bladder. The gallstones must not show as shadows on X-ray images and should not exceed 15 mm in diameter. The gall bladder must be functioning despite the gallstone(s). Paediatric population Hepatobiliary disorders associated with cystic fibrosis in children aged 6 to 18 years 4.2 Posology and method of administration There are no age restrictions on the use of Ursofalk tablets in the treatment of PBC and for the dissolution of radiolucent gallstones. For patients weighing less than 47 kg or patients who are unable to swallow Ursofalk tablets, Ursofalk capsules and suspension are available. The following daily dose is recommended for the various indications: For the treatment of primary biliary cirrhosis (PBC) The daily dose depends on body weight and ranges from 1½ to 3½ tablets (14 ± 2 mg of UDCA per kg of body weight). For the first 3 months of treatment, Ursofalk tablets should be taken divided over the day. With improvement of the liver values the daily dose may be taken once daily in the evening. Body weight (kg) Daily dose (mg/kg BW) Film-coated tablets first 3 months subsequently morning midday evening evening (1 x daily) 47 62 12 16 ½ ½ ½ 1½ 63 78 13 16 ½ ½ 1 2 79 93 13 16 ½ 1 1 2½ 94 109 14 - 16 1 1 1 3 Izlasiet visu dokumentu